Class III · Low risk
Fenofibric Acid Tablets 105 mg
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
National Drug Code
Is NDC 53489-0678-90 recalled?
Fenofibric Acid Tablets 105 mg
Yes — this exact package was recalled
2 FDA recalls name the code 53489-0678-90 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class III · Low risk
Fenofibric Acid
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 53489-0146 Sulfamethoxazole and Trimethoprim 2
- 53489-0677 See recall 2
- 53489-0120 Doxycycline Hyclate 1
- 53489-0143 Spironolactone 1
- 53489-0215 See recall 1
- 53489-0216 See recall 1
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